INJECTABLE ROCURONIUM BROMIDE SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

ROCURONIUM BROMIDE

Inapatikana kutoka:

OMEGA LABORATORIES LIMITED

ATC kanuni:

M03AC09

INN (Jina la Kimataifa):

ROCURONIUM BROMIDE

Kipimo:

10MG

Dawa fomu:

SOLUTION

Tungo:

ROCURONIUM BROMIDE 10MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0126317001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2023-07-10

Tabia za bidhaa

_PRODUCT MONOGRAPH: Injectable Rocuronium Bromide _
Page 1 of 33
PRODUCT MONOGRAPH
Pr
INJECTABLE ROCURONIUM BROMIDE
Rocuronium Bromide Injection
10 mg / mL, Solution for Injection, 5 mL vial
Sterile and Preservative Free
Non-depolarizing Skeletal Neuromuscular Blocking Agent
Omega Laboratories Limited
11177 Hamon
Montreal, Canada
H3M 3E4
Date of Preparation:
JUL 10, 2023
Submission Control No.: 276019
_PRODUCT MONOGRAPH: Injectable Rocuronium Bromide _
Page 2 of 33
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
12
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 17
STORAGE AND STABILITY
.........................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
......................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 25
PART II: SCIENTIFIC INFORMATION
..............................................................................
26
PHARMACEUTICAL INFORMATION
....